BEUDAMED
    FDA Adverse Event Injury Summary report: N

    35 CM BIPOLAR LEAD

    MDR report key: 4059081 · Received August 8, 2014

    Report

    Report Number
    2183787-2014-00095
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 25, 2014
    Report Date
    July 21, 2014
    Manufacturer
    GREATBATCH MED
    Product Code
    DTB
    PMA / PMN Number
    P130012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NA.

    Description of Event or Problem · 1

    A DEVICE REGISTRATION FORM WAS RECEIVED STATING THAT THIS LV LEAD WAS EXPLANTED DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473062 35 CM BIPOLAR LEAD BIPOLAR LEAD DTB GREATBATCH MED 511211 W1611713

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention